BIA Guided-fluid Management in Postinjury Open Abdomen

Not Applicable

Completed

• Conditions: Damage Control; Trauma Abdomen; Acute Compartment Syndrome
• Interventions: Other: BIA-guided fluid resuscitation protocol; Other: Traditional fluid resuscitation protocol

• Registration Number: NCT03466684
• Lead Sponsor: Nanjing PLA General Hospital

Brief Summary

Fluid overload (FO), resulting from high volume fluid therapy, is frequent and contributes to excessive visceral edema, delayed fascial closure, and adverse outcomes among postinjury open abdomen (OA) patients. Bioelectrical impedance analysis (BIA) is a promising tool in monitoring fluid status and FO. Thus, we sought to investigate the efficacy of BIA-directed resuscitation among postinjury OA patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2017-12-31
• Status Verified: 2018-03
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-15
• Study Completion: 2018-03-31
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Adult trauma patients admitted to SICU with OA after emergent abbreviated laparotomy were considered eligible.

Exclusion Criteria

• (a) age less than 18 years; (b) pregnancy; (c) lactation; (d) limb amputations; (e) mental disorders; (f) diabetes mellitus; (g) pre-existing blood disorders; (h) pre-existing abdominal fistulas; (i) pre-existing terminal illness; (j) liver dysfunction (Child-Pugh class C); (k) New York Heart Association (NYHA) class IV; (l) chronic renal failure requiring dialysis; (m) therapy with an extra-corporeal membrane oxygenator (ECMO); (n) enrolled in an ongoing, interventional RCT; (o) received prior fluids for resuscitation during their ICU stay; (p) expected to die within 1 hour of ICU admission for devastating injuries; (q) activated opt-out process for BGFM trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIA-directed fluid resuscitation	BIA-guided fluid resuscitation protocol	After the achievement of CVP, MAP and ScvO2 goals, if hyperhydration (HL \> 74.3%) was found, then the following fluid management was applied with each passing 6h. If HL was above 87% (severe level), fluid infusion was restricted, a furosemide drip was used, and CRRT was initiated with an ultrafiltration rate when patients were failure or inadequate response to above diuretic therapy that gave a net negative fluid balance of at least 1500 ml during the next 6h. If HL was 81%-87% (moderate level), above methods were used to trigger a net negative fluid balance (about 1000 ml) for the next 6h. Similarly, If HL was 74.3%-81% (mild level), a net negative fluid balance of about 500 ml would be achieved during the next 6h of ICU hospitalization. If HL was blow 71%, a state of dehydration, CVP, MAP, and ScvO2 was maintained as above during ICU resuscitation.
Traditional fluid resuscitation	Traditional fluid resuscitation protocol	A timely restricted intravenous fluid regimen or dehydration therapy was implemented by two senior clinicians according to cumulative fluid balance recording and hemodynamic condition such as heart rate, blood pressure, central venous pressure, mean arterial pressure, urine output and body weight change.

Primary Outcome Measures

Name	Time	Method
Rate of 30-day primary fascial closure	30 days	Rate of 100% direct approximation of abdominal fascial edges

Secondary Outcome Measures

Name	Time	Method
Time to fascial closure	30 days	Time to 100% direct approximation of abdominal fascial edges
Postoperative 7-day fluid volume	7 days	Statistics of postoperative 7-day fluid volume Postoperative 7-day fluid fluid use during resuscitation
Postoperative 30-day mortality	30 days	All cause mortality within 30 days
Postoperative 30-day adverse effects	30 days	All cause adverse effects within 30 days